Vessel with sterile closure for separate storage of at least two substances



Dec. 11, 1956 E. JENSEN VESSEL WITH STERILE CLOSURE F0 OF AT LEAST TWUBS NCES Filed 001:. 1953 EPARATE STORAGE United States Patent Ofi ice2,773,591 Patented Dec. 11, 1956 VESSEL WITH STERILE CLOSURE FORSEPARATE STORAGE OF AT LEAST TWO SUBSTANCES Erik Jensen,Copenhagen-Vanlose, Denmark, assignor to Novo Terapeutisk LaboratoriumA/S, Copenhagen, Denmark, a limited liability company of DenmarkApplication October 15, 1953, Serial No. 386,318

Claims priority, application Denmark October 22, 1952 4 Claims. (Cl.20647) The invention relates to a vessel with sterile closure forseparate storage of at least two substances, which can be broughttogether before use without breaking the sterile closure. Such vesselsare used e. g. as ampuls for medicaments to be injected in the form ofsolutions or suspensions, which do not remain stable for a prolongedperiod and there-fore must be produced immediately before injection.

Vessels of this kind generally consist of a housing which at one of itsends is closed by means of a diaphragm, and wherein there is provided apartition to divide the housing in compartments for the reception of thesubstances.

It has been known to manufacture the partition between the compartmentsof resilient material and to pierce it with a needle, e. g. the needleof a hypodermic syringe, which is used for the subsequent injection. Bythis means, however, only a small aperture is provided in the partition,thereby rendering the mixing of the substancesdiflicult, even though thesyringe can be utilized for this purpose. It has also been proposed tomanufiacture the partition of thin glass plate having a local weakeningand a cast-in ferromagnetic member, which can be influenced by a magnetfrom the exterior side of the vessel to break the partition. Such adevice, however, is difiicult to manufacture and complicated inoperation. Other known devices for the said purpose suffer from similardrawbacks.

The main object of the invention is to avoid these drawbacks. v

Another object is to provide Ia vessel of the kind in question in whichthe substances contained therein will be'retained in sterile conditioneven during a long storage.

A further object is to indicate an arrangement by which the partition inthe vessel can 'be breaked by an outward pressure on the diaphragm, e.g. by means of a finger.

Finally, Ia still further object is to provide a vessel for the purposedescribed of a cheap and reliable construction and easy to handle inuse.

With the above and other objects in view the present invention consistsin the combination and arrangement of parts, hereinafiter more fullydescribed, illustrated in the accompanying drawings and morespecifically pointed out in the claims, it being understood that changesmay be made in the form, size, proportions, and details of constructionwithout departing from, or sacrificing any of the advantages of theinvention.

In the drawings:

Fig. 1 is a longitudinal section of a vessel embodying the invention,

Fig. 2 is [a transverse section thereof on the line II-II in Fig. 1,

Fig. 3 is a longitudinal section of another embodiment,

Fig. 4 shows on a larger scale that part of Fig. 3 which is framed indot-and-dash lines,

Figs. 5 and 6 are illustrations of the same part with the members inother relative positions, and

Fig. 7 shows a variant of the embodiment according to Fig. 3.

The vessel shown in Figs. 1 and 2 consists of a tubular housing 10,which is suitably manufactured of transparent material, e. g. glass orplastic. At one end, the housing has an expanded mouth 12, which isclosed by a resilient diaphragm in the form of a cap 14, manufactured e.g. of rubber, said cap comprising a slightly arched part 16 and a collar18, which embraces the expanded end of the housing, fitting hermeticallytight thereto.

At the internal side of the arched part 16 there is provided aprojection 20 with a recess receiving one end of a rod 22, which mayconsist of the same material as the housing 10.

The lowermost end of said rod abuts against a partition 24, which in theembodiment described as cast integral with the housing 10. In one faceof the partition 24 there are provided various weakening lines, which e.g. as shown in Fig. 2 may consist of a circular groove 26 and :a numberof radial grooves 28, the preferred section of which is V-shaped.

The lowermost end of the housing 10 is hermetically closed by means of aclosure frequently used for ampuls and manufactured in the followingmanner. The open end of the housing is surrounded by a collar 30, thesection of which is trapeziform. On the mouth of the housing there isplaced an elastic disc 32, e. g of rubber, which by means of a metalring 34 pressed around said collar is maintained in tight abutmentagainst the end face of the housing and the outermost cone-shaped faceof the collar 30.

Before putting on the cap 14 there is supplied a e. g.

fluid solvent 36 to the uppermost compartment of the housing 10 abovethe partition 24. -In like manner there is placed a pulverulentmedicament 38 in the lowermost compartment below the partition 24 beforeproviding the closure 32, 34. The medicament and the solvent are keptcompletely separate by the partition 24, until the medicament is to beused. When, immediately before use, the solvent has to be added to themedicament, pressure is exerted on the arched part 16 of the cap 14,whereby said part is bent inwardly like a diaphragm and carries with itthe rod 22, the lowermost endviof which thereby breaks through thepartition 24, which will preferably break in the grooves 26 and 28,whereby the pieces thus broken off will fall to the bottom of thehousing 10. The dissolultion of the powder in the liquid may beaccelerated by shaking the housing.

The dissolved medicament may be removed by means of an inject-ionsyringe, piercing the disc 32 with its needle.

In the embodiment shown in Fig. 3, the housing 10 is closed below afixed bottom 40, which is cast integral with its tubular lateral wall.Above, the housing 10 is shaped and hermetically sealed as described inthe foregoing, excepting only that the arched part 16 of the cap 14 isnot provided with an internal projection. The construction and function,however, of the partition between the medicament 38 and the solvent 36present considerable deviations.

In this case the partition is constituted by a rigid discshaped body 42,made e. g. of metal, and an elastic ring 44 surrounding said body, thecross-section of the ring being rounded, preferably circular. The ring44 may consist of rubber, especially butyl rubber (GR-I) which isimpervious to steam. The circumference of the disc-shaped body issuitably circular, so that a gap, having the same width everywhere, willbe provided along the periphery, when the body is disposed CO-iflXliillYin the housing 10, the section of which is circular. In said gap thering 44 is so disposed that it is subject to a pressure sufficient toprovide safe tightening between the body 42 andythe wall of the housing.A groove 46 is preferably provided at the edge of the body 42, in whichgroove the ring 44 normally rests.

To the uppermost side of the body 42 .there is attached a rod 48, thefree end of which abuts against the arched part 16 of the cap 14.

When the partition is to be broken, the arched part 16 of the cap 14 isforced downwardly like a diaphragm. Thereby a pressure is transferredthrough the rod 48 to the disc-shaped body 42, and as a consequencethereof the ring 44 .will be unrolled between the wall of the housing 10and the edge of the body 4-2, as illustrated in Figs. 4-6. In Fig. 4 theparts assume the same relative positions as in Fig. 3. In Fig. 5 thering 44 has left the groove 46, and the uppermost part of the edge ofthe body 42 has been pressed slightly into the ring 44-, therebyincreasing the stress of same. The body 42 will then be in a position oflabile equilibrium, which is exceeded by its subsequent movement, seeFig. 6. The stress in the ring 44 will thereupon throw the body- 42downwardly towards the bottom 41 of the housing, which movement,however, is braked by the powder 33. Simultaneously, the liquid fallsdown into the powder, and the dissolution of same in the liquid isinitiated and may thereupon be continued and completed by shaking thehousing 10, the free body 42 serving as a stirring device. In Figs. 4-6an arrow indicates the pressure exerted by the ring 44 on the body 42.

The construction described presents the special advantage that a largeaperture is provided between the compartments of the vessel, when thepartition is broken.

The dissolved medicament may be removed by means of an injectionsyringe, the needle piercing the arched pant 16 of the cap 14.

In the process of filling the vessel 10, the cap 14 is removed and themedicament 38 is deposited. Thereupon the body 42 surrounded by the ring44 is inserted, a downwardly pressure being exerted on said ring bymeans of the edge of a tube having the same diameter as the ring, so asto prevent the unrolling of the ring during the insertion. Finally, thesolvent is supplied to the uppermost compartment, and the cap 14 is puton.

In the embodiment shown in Fig. 7, which difiers slightly only from thatshown in Fig. 3, the vessel is formed as a pipette, e. g. for drippingeyes. For this purpose the bottom of the housing 10 is provided with aneck 50, normally closed by a removable cap 52 forming a tight seal.When the fluid 36 and the medicament 38 have been mixed, as heretoforedescribed, the cap 52 is removed, and after the vessel has been turnedwith the neck 50 downwards .the contents can be discharged drop by dropby successively exerting slight pressures on the diaphragm 14.

The vessel in question may be manufactured with more than twocompartments by incorporating additional pantitions. The embodimentaccording to Fig. 3 may thus have several bodies 42 with appurtenanttightening rings 44 and actuating rods 48. The free end of the rod on asubsequent body will then have to abut against the preceding body. Bypressing the arched part 16 of the cap 14 the pressure will betransferred from one body 42 to the next one, and all bodies will bereleased simultaneously.

Having thus fully described my invention I claim as new and desire tosecure by Letters Patent:

1. A sterile closed vessel for separate storage of at least twosubstances which are adapted to be intermixed before use whichcomprises, means defining a housing having at least one open end, atransverse partition in said housing dividing it into adjacentcompartments for the respective reception of said substances, aresilient diaphragm closing an open end of said housing, and a memberextending between said diaphragm and said partition for displacing saidpartition inwardly of said housing upon inward movement of saiddiaphragm, said partition comprising a disc-shaped body and an elasticring having a substantially circular cross-section frictionally disposedbetween the periphery of said body and the inner surface of the housing,said partition normally sealing the adjacent compartments from oneanother but inwardlydireoted pressure applied to said diaphragm andtransmitted through said member to said body causing said body to bedisplaced inwardly while said elastic ring rolls over the housing wallto provide free communication between said compartments.

2. A vessel as defined in claim 1, wherein said discshaped body isprovided along its periphery with a continuous groove in which saidelastic ring .is seated.

3. A vessel as defined in claim 1, wherein said member comprises a rodsecured to said body and having a free end abutting against saiddiaphragm.

4. A vessel as defined in claim 1, having a second open end in the formof a neck and a removable seal closing said open end.

Smith Mar. 10, 1942 Smith June 23, 1953

